In Europe, Access to New Medications Takes Time

Two Studies Examine Delays in Patient Access To New Medications in EU Countries

September 28, 2000

New medications are a critical component of health care. Yet patients in many European Union countries face significant delays — sometimes in excess of four years or more — before gaining access to breakthrough drugs, even after they have become available in other EU member countries.

If patients are to have access to these innovative medicines, the products must be launched in a timely manner, bought and sold at a reasonable price, and reimbursed at the appropriate level.

Two new studies by Europe Economics, a research organization in London, conclude that these delays are a direct result of national procedures that determine the pricing and reimbursement levels for every new drug.

As a result, several EU countries deny their residents the benefits of new treatments that already are available to the citizens of other EU member states.

BACKGROUND

Pricing and Reimbursement Procedures Delay Access to New Medicines

In most European countries, pharmaeutical companies must obtain pricing and reimbursement approvals from national governments before they can launch new medicines onto the market. These delays come after the medicines have been approved by the national ministries of health in each state or by the European Agency for the Evaluation of Medicines (EMEA).

The studies by Europe Economics found that delays occurred in Belgium, the Netherlands, France, Italy, Portugal, and Greece. In light of discussions of EU enlargement, one Eastern European country also was included in the study. The analysis showed that access to modern drugs in Poland is even more limited than access in EU member states.

In Portugal, Greece, and Belgium, for example, companies must make separate applications for pricing and for reimbursement, often to different ministries. The companies normally cannot sell their products until the relevant pricing authorities have established the price and reimbursement rates, which can take 18 months on average.

By contrast, in Sweden, where companies are free to set their own prices and then negotiate reimbursement levels with the government, the delay to launch approved drugs onto the market is less than three months on average.

KEY FINDINGS

EU Patients Face Significant Delays for Access to Medicines

In one study of breakthrough medicines available between 1986 and 1996, Europe Economics found patients in some EU countries suffered long delays in obtaining widely prescribed drugs. Products included in this study are inter alia Prozac, Zoloft, Norvasc, and, Zocor.

Patients in some EU states had to wait an average of two years to gain access to a new drug, even after it was on sale in another EU country.

The study finds a four-year gap on average between the nation with the fastest approval process and the nation with the slowest approval process.

Many Life Saving Drugs Are Simply Unavailable in Some Countries

Because of these delays, many breakthrough medications are simply unavailable for millions of EU citizens for extended periods of time.

Patients in Spain, Greece, and Portugal waited nearly three years for access to a major new cardiovascular drug after it was available in other EU countries.

Patients were forced to wait for over four years in Greece and Portugal and for three years in Belgium and France before they could use a major new anti-infective therapy already available in other EU countries.

Patients who needed a major new nervous system medication were denied access for nearly six additional years in Portugal and three years in France.

The Europe Economics? study of medications approved under a new mutual recognition procedure found that delays remain significant:

Between 1995 and 1997, more than half of the new medications surveyed were unavailable through pharmacies in Portugal, Italy, and Greece.

More than one-third were unavailable in Belgium, France and the Netherlands.

In Greece, 91 percent of pharmaceutical products seeking reimbursement had not yet been approved for reimbursement.

In Portugal, 70 percent of pharmaceutical products seeking reimbursement had not yet been approved for reimbursement.

In Belgium, 55 percent of pharmaceutical products seeking reimbursement had not yet been approved for reimbursement.

Reimbursement Delays Deny Patient Access to Medicine

In several EU countries, a separate process exists for awarding a price to a new medicine and granting a reimbursement rate. Without an approved reimbursement rate, these medicines remain effectively out of reach of most patients.

One study finds that Belgium, Greece, and Portugal have created extraordinary delays between the time they award a price to a drug and the time they set the reimbursement level.

Belgium took an average of 102 days to price new medicines, but an additional 464 days to award a reimbursement level.

Greece took an average of 264 days to price new medicines, but an additional 278 days to award a reimbursement level.

Portugal took an average of 66 days to price new medicines, but an additional 452 days to award a reimbursement level.

New Centralized Process Does Not Decrease Delays

In 1995, EU Members began a centralized, marketing authorizing process intended to ensure ?rapid access? to new medications. One of Europe Economics? two studies found that this central approval process did not decrease delays in the pricing and reimbursement processes required by the member states.

THE DANGER OF DELAYS

Compromising the Quality of Health Care: Delaying patient access to new medications compromises the quality of health care for millions of patients in EU member states. In recent years, EU patients have been denied access to breakthrough medications to treat cardiovascular problems, respiratory ailments, urinary system infections, and other illnesses.

Discriminating by Country: The wide variance in delays among EU members creates a medical environment in which patients are discriminated against based on their country of residence. Patients living in Greece, Portugal, Belgium, or France experience much longer delays than patients in Sweden, Germany, or the U.K.

Obstructing the Goals of Quality Health Care:The European Union, pharmaceutical companies, patient groups, and medical professionals all agree that rapid access to approved medications is vital to improving the health care all patients receive. The excessive delays in some EU countries are clearly lowering the quality of health care for millions of patients.

Jeopardizing Medical Innovation: Breakthrough medications require years of research, development and testing. According to one estimate, the average cost of developing a new drug was $500 million. On average, only about three out of every 10 drugs approved ever recovers R&D costs. Unnecessary delays in patient access to new pharmaceuticals restrict the patented life of medications, reduce incentives for investment, and ultimately jeopardize medical innovation.

GETTING MORE INFORMATION

The two studies by Europe Economics are:

“Patient Access to Major Pharmaceutical Products in EU Member States,” an analysis of the delays in 22 breakthrough medications that had received marketing authorization in at least one member state and 24 medications which had been given a Community Marketing Authorization.

“Patient Access to Pharmaceuticals Approved through Mutual Recognition,” an examination of delays in the availability of medications under the Mutual Recognition procedure established in 1995.